DE102020205546A1 - Monitoring procedure and medical system - Google Patents

Abstract

For improved patient safety, a method for the automatic monitoring of a robot-assisted movement of a medical object carried out by a robotic system through a hollow organ of a patient is provided with the following steps: Tracking the movement of the medical object by means of a medical imaging device in such a way that the medical object and / or the hollow organ is at least partially arranged in the recording area that can be mapped by the imaging device, the tracking being effected by a relative movement between the recording system of the imaging device and the patient, recording of at least one image of the recording area during the tracking, with one at regular intervals in each case Another image is recorded, evaluation of the respective current image and / or of sensor data of a sensor assigned to the robotic system or the object to determine whether a related to the robotic Sy system decision and / or security-relevant situation is present, and output of information when the evaluation shows the existence of a decision and / or security-relevant situation.

Description

The invention relates to a method for automatically monitoring a robot-assisted movement of a medical object according to patent claim 1 and to a device for carrying out such a method according to patent claim 7.

Interventional medical procedures in hollow organs, e.g. the vascular system of the human body, require medical objects, e.g. devices or instruments, to be introduced into the vascular system via a percutaneous vascular access and to be guided to the target region to be treated. Conventionally, the practitioner introduces the objects, for example guide catheters, microcatheters or guide wires, under X-ray fluoroscopy through a lock into the vascular system and then navigates the object into the target region with the help of contrast medium injections to make the vessels visible. In many cases, the practitioner stands directly at the patient's table, supported by his or her assistant, to carry out the procedure.

A further development of this medical procedure connects a robotic system between the hands of the practitioner and the patient, with the advantage that the practitioner no longer has to stand directly at the table for the patient, but maneuvering the objects (rotation, forward and backward movement) is remotely controlled can perform. In principle, such robotic systems are known, by means of which a (semi-) automatic advance of an object, for example a catheter and / or guide wire, can be brought about in a cavity organ of a patient with the aid of a robot, for example from the EP 3406291 B1 . For this purpose, the practitioner is provided with a corresponding user interface for the remote-controlled movements. In addition, it is advantageous to record fluoroscopic images of an X-ray system for the necessary visual feedback, to transmit them and to display them to the practitioner. The advantage of this robotic guidance of the medical object lies, among other things, in the comfortable working position of the practitioner, the possibility of being able to leave the radiation area at the patient table completely and thus greater work safety through avoidance of radiation.

It is the object of the present invention to provide a method which enables a further automation of such a procedure; Furthermore, it is an object of the invention to provide a medical system suitable for carrying out the method.

The object is achieved according to the invention by a method for automatically monitoring a robot-supported movement of a medical object by a robotic system according to claim 1 and by a device according to claim 7. Advantageous embodiments of the invention are each the subject of the associated subclaims.

The method according to the invention for the automatic monitoring of a robot-assisted movement of a medical object, in particular an instrument, carried out by a robotic system through a hollow organ of a patient comprises the following steps: Tracking the movement of the medical object by means of a medical imaging device in such a way that the medical object and / or the hollow organ is at least partially arranged in the recording area that can be mapped by the imaging device, the tracking being effected by a relative movement between the recording system of the imaging device and the patient, recording of at least one image of the recording area during the tracking, with a further image at regular intervals is recorded, evaluation of the current image and / or of sensor data of a sensor assigned to the robotic system or the object to determine whether an ent in relation to the robotic system situation relevant to a decision and / or security is present, and output of information if the evaluation reveals the existence of a situation relevant to decision and / or security.

In principle, robotic systems are known by means of which a (semi-) automatic advance of an object, for example a catheter and / or guide wire, can be brought about in a cavity organ of a patient with the aid of a robot, for example from the EP 3406291 B1 . For this purpose, the practitioner is provided with a corresponding user interface for the remote-controlled movements. The inventive method enables further automation through additional automatic monitoring, so that in addition to improved safety in the known semi-automatic method, for example, the feed can also be effected fully automatically on the basis of path planning. In addition, patient safety is further improved with such methods, since automatic, seamless monitoring of the feed movements is guaranteed and critical situations or termination criteria can be reacted to immediately. Overall, a medical imaging device, for example an X-ray device, follows the advance of the object, so that the object is always arranged in the recording area of the imaging device. This means an advantageous synchronization with the imaging device. The tracking can be carried out either by moving the recording system of the imaging device or by moving the Patient table / the table top of the patient table on which the patient is positioned or can be carried out by moving the recording system and patient table together relative to one another.

During the tracking, another current image is regularly recorded and evaluated, e.g. by means of image recognition and / or image processing algorithms and / or by means of pre-trained machine learning algorithms. The evaluation is carried out to determine whether a decision-making and / or safety-relevant situation is present, and if this is the case, information is output. Information can be output in various ways, e.g. by displaying an image, displaying optical signals or outputting acoustic or haptic warnings. An operator can thereby be made aware that an action or intervention is required. In addition to evaluating the images from the imaging device, additional information from sensors and other devices can also be used to point out decision-making and / or safety-relevant situations, e.g. navigation devices, cameras or sensors arranged on the object.

According to one embodiment of the invention, in addition to an information display (e.g. on a screen), a control signal to interrupt the robot-assisted movement and / or the image recording is automatically output if the evaluation reveals that a decision-making and / or security-relevant situation is present. Such an interruption is a safety measure to prevent a path deviation or even an injury or damage to the hollow organ from occurring due to a further advance of the object. This protects the patient and ensures that an examination can be carried out optimally.

According to a further embodiment of the invention, the current image, the evaluation of which reveals the presence of a decision-making and / or security-relevant situation, and / or the current image, which at the same point in time of the sensor data, which results in the presence of a decision-making and / or security-relevant situation , was recorded, displayed, in particular until a user input has been received or until a control command has been received to resume the robot-assisted movement and / or the image recording. This is a so-called last image hold ( LIH ), in which the critical image is displayed permanently in order to give the operator the opportunity to examine the critical situation in detail and possibly to initiate measures to resolve the situation (e.g. withdraw the object part of the path, take a certain branch of the hollow organ to make the movement slow, to initiate a dose of contrast agent, etc.). After the situation has been resolved, the operator can then, for example, make the decision to resume the robot-assisted movement and thus also to resume the method according to the invention.

According to a further embodiment of the invention, the tracking takes place at least partially on the basis of control signals from the robotic system. The control signals can be transmitted to the imaging device in order to give its system control the possibility of improving the corresponding subsequent movement of the recording system or the patient table and making it even more precise.

Advantageously, a decision-making and / or security-relevant situation is present when a junction, a bifurcation, a peculiarity or other anomaly of the hollow organ is detected during the evaluation (of the respective image or sensor signal) or if a deviation from an existing path planning of the Object exceeds a predetermined or preset threshold value, for example.

According to a further embodiment of the invention, there is a path planning for an automatic or semi-automatic movement of the medical object. This can also be used, for example, to simplify the tracking of the imaging device and to decide whether a decision-making and / or security-relevant situation exists.

The invention also includes a medical system for performing a method described above, having a robotic system with at least one robot control unit and a robot-supported drive system with a drive and a drive mechanism, the drive system being designed to use control signals from the robot control unit to produce a medical object to move in a cavity organ of a patient, as well as having an imaging device with a system control unit and a movable recording system for recording images of an imageable recording area, the system controller being designed to control the recording system for tracking the movement of the medical object, also having an evaluation unit for Evaluation of images of the recording system to determine whether there is a decision-making and / or safety-relevant situation with regard to the robotic system, and having a e Output unit for outputting information. The output unit is advantageously a display unit educated. In addition, the medical system can include an input unit for controlling the robotic system by an operator.

In an advantageous manner for improved tracking of the object by the imaging device, the robot control unit and the system control unit are designed to exchange data.

According to one embodiment of the invention, the medical system has a patient table with a table top, the patient table and / or the table top being controllable to perform a movement relative to the recording system. In this way, the tracking can also or exclusively be carried out by moving the patient table / table top (that is, the patient) relative to the recording system. This can be, for example, translational movements or tilting movements.

According to a further embodiment of the invention, the medical system has a position determination system with at least one sensor, which sensor is arranged on or assigned to the robotic system or the object, the position determination system being designed to determine a position of the object. The position determination system sends the position information to the imaging device in order to facilitate tracking and to be able to better evaluate situations relevant to decisions and / or safety.

• 1 eine Abfolge von Schritten des erfindungsgemäßen Verfahrens;
• 2 eine Ansicht eines medizinischen Systems gemäß der Erfindung;
• 3 eine weitere Abfolge von Schritten eines Verfahrens nach 1; und
• 4 eine Ansicht eines Positionsbestimmungssystems mit an dem Objekt angeordnetem Sensor.

The invention and further advantageous configurations according to the features of the subclaims are explained in more detail below with reference to exemplary embodiments shown schematically in the drawings, without thereby restricting the invention to these exemplary embodiments. Show it:

• 1 a sequence of steps of the method according to the invention;
• 2 a view of a medical system according to the invention;
• 3 a further sequence of steps of a procedure according to 1 ; and
• 4th a view of a position determination system with the sensor arranged on the object.

In the 1 steps of a method for automatically monitoring a robot-assisted movement of a medical object through a hollow organ of a patient carried out by a robotic system are shown. In the 2 is a medical system 1 shown, which is designed to carry out the method.

The medical system 1 has a robotic system and an imaging device, such as an X-ray machine 10 , on. The robotic system is for the semi-automatic or automatic advancement of at least one object, for example an instrument, stent, guide wire 5 or catheter, in a hollow organ of a patient 15th educated. A semi-automatic control is, for example, one by an operator via an input unit 17th (e.g. joystick, touchpad, rotary control, ...) to a robot control unit 8th understand transferable control. The robotic system has at least one robot control unit 8th and a robotic drive system 7th on. The drive system 7th is designed to be based on control signals from the robot control unit 8th the medical object, e.g. a guide wire 5 , after being introduced at an entry point 6th in a cavity organ of a patient 15th to move. The drive system 7th comprises at least one drive and a drive mechanism (not shown, for example known from US Pat EP 3406291 B1 ), which drive mechanism e.g. with the guide wire 5 is releasably coupled. By means of the drive mechanism and the drive, the guide wire 5 axially advanced and withdrawn and / or additionally moved rotationally. The robot control unit 8th is with an input unit (for example arranged remotely from the patient) 17th connected, which an operator, such as a surgeon, can operate. The control signals are from the input unit 17th (e.g. one or more joysticks, touchpads, control buttons, etc.) to the robot control unit 8th and in this way the movements of the object are controlled semi-automatically. Alternatively, the operator can also plan a path for the object or have it created automatically. This is sent to the robot control unit 8th and so a fully automatic movement can take place. The path planning can also be used as a reference for a semi-automatic movement.

In order to have an overview of the intervention and the movement, the imaging device is, for example, an X-ray device 10 , intended. The X-ray machine 10 has a C-arm, for example 13th on which an X-ray source 12th and an X-ray detector 11 holds and with a control panel 16 connected is. The C-arm 13th is arranged to be movable relative to the patient; in the case of a mobile x-ray device, the entire x-ray device can also be moved. Alternatively or additionally, the patient table can also be used 14th or just the plate 19th of the patient table 14th be moved relative to the X-ray device or recording system. Using the X-ray machine 10 can images of a mappable Recording area created and attached to a display unit 18th are displayed. The robot control unit 8th and the control panel 16 of the imaging device can exchange data bidirectionally and communicate with one another. It is also possible to provide a common control which the robot control unit 8th and the control panel 16 includes.

Follow-up takes place within the scope of the method according to the invention NW the movements of the object through the imaging. In order to be able to observe the movements of the object through the hollow organ, it is important that the object and / or the hollow organ are always at least partially arranged in the recording area of the recording system of the imaging device. This can be done, for example, by moving the recording system along the path of the object and / or moving the patient table 14th take place relative to the recording system, which movements can be controlled by the system control of the x-ray device. There are several ways to accomplish such tracking. In particular, control signals of the robotic system can be sent from the robot control unit 8th to the control panel 16 passed on and used for follow-up or at least included. Path planning that has already been made can also be used to control or optimize tracking. In addition, additional positioning systems can also be used to determine the position of the object and use it for tracking. A position determination system can, for example, by means of at least one sensor, for example a position sensor 21 - please refer 4th - on the object and an associated readout unit 22nd determine the exact position of the object.

During the follow-up NW the recording takes place B1 at least one first image (e.g. fluoroscopic image) of the recording area, with a further image recorded continuously or at regular intervals ( B2 ... BN ) and, for example, also on the display unit 18th is shown. The display unit 18th shows the current image in each case so that the operator has an overview of the advance of the object. As soon as the recording B1 of the first image is done, the first image is displayed D1 . Is the recording B2 of the second image occurs, the display will D2 of the second image carried out, etc. The respective recorded image is also evaluated directly online to this effect AW whether there is a decision-making and / or safety-relevant situation with regard to the robotic system. For this evaluation AW For example, with the aid of image recognition, the image is analyzed with regard to whether there is a junction, a bifurcation, a peculiarity or an anomaly of the hollow organ. An analysis can also be carried out to determine whether a deviation of the path of the object from an existing path planning exceeds a specific, for example preset, threshold value and / or whether another error tolerance is exceeded. When evaluating AW With regard to a decision-making and / or safety-relevant situation, in addition to the images, additional data, for example that of a position determination system or of another measuring system or sensor, can also be included.

If the evaluation shows a non-critical situation NC so the process is continued by the follow-up NVV and the recording Bk , Display Dk and evaluation AW of further images takes place (where k = 1, 2, ..., N).

Results in the evaluation after the exposure BN of the Nth image for this one decision-making and / or safety-relevant situation CRIT , a control signal for abortion or interruption is automatically sent immediately UB the robot-assisted movement and the image acquisition. At the same time the display DN of the N-th image is elongated LIH , in particular until a user input is received IN for ending the display or resumption of the method or until receipt of a control command to resume the robot-assisted movement and / or the image acquisition - see e.g. 3 . So there is a so-called last image hold LIH so that the critical Nth image remains visible to an operator until canceled. The last image hold LIH takes place with the current image, the evaluation of which has resulted in a critical situation or which has just been recorded or displayed, i.e. a critical situation has been detected. In this way, the operator can examine and analyze the critical situation in detail while the movements are not continued. As a result, the operator can, if necessary, initiate measures to resolve the situation or simply the interruption UB the robot-assisted movement and / or the method, for example through an input IN lift.

In addition, further signals, such as optical, acoustic or haptic warning signals, can be output together with the interruption. Requests or suggestions for certain actions can also be issued and displayed to the operator, e.g. a suggestion for the administration of contrast medium (e.g. if the decision-making and / or safety-relevant situation was that the hollow organ was no longer recognizable in the image) , a proposal for a path correction (e.g. if a threshold value for a path deviation from a planned path is exceeded), a proposal for a A diversion (e.g. in the case of a bifurcation) or a suggestion for slowing down the movement.

Optical, acoustic or haptic signals can also be used during the follow-up NW can be output without a decision-making and / or safety-relevant situation, for example to provide information about the progress of the movement of the object or to indicate the accuracy of the control with regard to the planned path.

As an alternative to an X-ray device with a C-arm, other imaging devices, e.g. a computer tomograph or a magnetic resonance tomograph, can also be used.

The invention can be briefly summarized as follows: For improved patient safety, a method for automatically monitoring a robot-supported movement of a medical object through a hollow organ of a patient carried out by a robotic system is provided with the following steps: Tracking the movement of the medical object by means of a medical imaging device in such a way that the medical object and / or the hollow organ are at least partially arranged in the recording area that can be mapped by the imaging device, the tracking being effected by a relative movement between the recording system of the imaging device and the patient, recording of at least one image of the recording area during the tracking, with a further image being recorded at regular intervals, evaluation of the current image and / or of sensor data associated with the robotic system or the object Neten sensors to determine whether there is a decision-making and / or safety-relevant situation with regard to the robotic system, and output of information if the evaluation reveals the existence of a decision-making and / or safety-relevant situation.

QUOTES INCLUDED IN THE DESCRIPTION

This list of the documents listed by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent literature cited

• EP 3406291 B1 [0003, 0007, 0020]

Claims (12)

Method for the automatic monitoring of a robot-supported movement of a medical object, in particular an instrument, carried out by a robotic system through a hollow organ of a patient, with the following steps: • Tracking (NW) of the movement of the medical object by means of a medical imaging device in such a way that the medical object and / or the hollow organ are at least partially arranged in the recording area that can be mapped by the imaging device, the tracking by a relative movement between the recording system of the imaging device and the Patient is effected • Recording (B1) at least one image of the recording area during the follow-up, with a further image being recorded at regular intervals (B2 ... BN), • Evaluation (AW) of the current image and / or of sensor data from a sensor assigned to the robotic system or the object to determine whether a decision-making and / or safety-relevant situation is present in relation to the robotic system, and • Output of information if the evaluation reveals the existence of a decision-making and / or security-relevant situation (CRIT). Procedure according to Claim 1 , wherein the tracking (NW) takes place at least partially on the basis of control signals of the robotic system. Method according to one of the preceding claims, wherein a control signal to interrupt the robot-assisted movement and / or the image recording is automatically output (UB) if the evaluation reveals a decision-making and / or security-relevant situation (CRIT) and the information is displayed . Procedure according to Claim 3 , the current image, the evaluation of which reveals the existence of a decision-making and / or security-relevant situation and / or the current image, which is recorded at the same point in time as the sensor data that indicate the existence (CRIT) of a decision-making and / or security-relevant situation is displayed (LIH) until receipt of a user input (IN) or until receipt of a control command to resume the robot-assisted movement and / or the image recording. Method according to one of the preceding claims, wherein a decision-making and / or safety-relevant situation is present (CRIT) if a junction, a bifurcation, a peculiarity or an anomaly of the hollow organ is detected during the evaluation or if a deviation from an existing path plan sets a threshold value exceeds. Method according to one of the preceding claims, wherein there is a path planning for an automatic or semi-automatic movement of the medical object. Medical system (1) for performing a method according to one of the Claims 1 until 6th , comprising a robotic system with at least one robot control unit (8) and a robot-assisted drive system (7) with a drive and a drive mechanism, the drive system (7) being designed to, on the basis of control signals from the robot control unit (8), a medical object in to move a cavity organ of a patient (15), as well as having an imaging device with a system control unit (16) and a movable recording system (11; 12; 13) for recording images of an imageable recording area, the system control unit (16) being designed to To control the recording system (11; 12; 13) for tracking the movement of the medical object, also having an evaluation unit (20) for evaluating images of the recording system (11; 12; 13) to determine whether a decision-making and / or there is a security-relevant situation, and having an output unit for output but information. Medical system according to Claim 7 , wherein the output unit is formed by a display unit (18). Medical system according to Claim 7 or 8th , having an input unit (17) for controlling the robotic system. Medical system according to one of the Claims 7 until 9 , wherein the robot control unit (8) and the system control unit (16) are designed to exchange data. Medical system according to one of the Claims 7 until 10 , comprising a patient table (14) with a table top, the patient table (14) and / or the table top (19) being controllable to perform a movement relative to the receiving system (11; 12; 13). Medical system according to one of the Claims 7 until 11 , comprising a position determination system (22) with at least one sensor (21), which sensor (21) is arranged on or assigned to the robotic system or the object, the position determination system (22) for this purpose is designed to determine a position of the object.

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